Exactech recalls specific Equinoxe Glenoid implants due to packaging lacking an oxygen barrier layer (EVOH), which may affect long-term stability. Check your item numbers and serial numbers to see if you're affected.
The packaging of these affected UHMWPE humeral liners and glenoids are nonconforming as they do not meet the established packaging specification. They were packaged in vacuum bags that did not contain an additional oxygen barrier layer consisting of Ethylene Vinyl Alcohol (EVOH).
Exactech is recalling certain Equinoxe Glenoid implants because their packaging doesn't include the required oxygen barrier layer (EVOH). This could potentially affect the long-term stability of the implants. Affected items have specific item numbers and serial numbers listed in the recall.
The packaging of these implants uses vacuum bags without an additional oxygen barrier layer (EVOH). This could potentially allow moisture to enter the packaging over time, which might affect the long-term stability of the implants.
Patients who received the recalled Equinoxe Glenoid implants (specifically the small, medium, and large sizes) during shoulder arthroplasty procedures. The risk is low as the packaging issue doesn't cause immediate harm but may affect long-term stability.
Check if your implant has item numbers 314-01-12 (small), 314-01-13 (medium), or 314-01-14 (large). The serial numbers listed in the recall include specific numbers starting with 0744170 through 1984870.
Identify if your implant matches the item numbers 314-01-12 (small), 314-01-13 (medium), or 314-01-14 (large) with the serial numbers listed in the recall.
The packaging of these implants uses vacuum bags without an additional oxygen barrier layer (EVOH), which could potentially affect long-term stability.
Yes, you should check if your implant matches the specific item numbers and serial numbers listed in the recall. If it does, contact Exactech for further instructions.
This is a low-risk issue as the packaging defect does not cause immediate harm but may affect long-term stability of the implants.
We’ve drafted a message you can send Exactech to request your refund or repair — edit it as you like.
Subject: Recall Z-1403-2024 — Exactech Exactech Hello, I own a Exactech that is covered by recall Z-1403-2024 from Exactech. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
